EP1707177B1 - Improvements in and relating to stoma devices and to dressings - Google Patents
Improvements in and relating to stoma devices and to dressings Download PDFInfo
- Publication number
- EP1707177B1 EP1707177B1 EP06251675A EP06251675A EP1707177B1 EP 1707177 B1 EP1707177 B1 EP 1707177B1 EP 06251675 A EP06251675 A EP 06251675A EP 06251675 A EP06251675 A EP 06251675A EP 1707177 B1 EP1707177 B1 EP 1707177B1
- Authority
- EP
- European Patent Office
- Prior art keywords
- stem
- stoma
- suitably
- dressing
- adhesive
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Not-in-force
Links
- 230000005012 migration Effects 0.000 claims abstract description 3
- 238000013508 migration Methods 0.000 claims abstract description 3
- 239000000853 adhesive Substances 0.000 claims description 23
- 230000001070 adhesive effect Effects 0.000 claims description 23
- 238000000034 method Methods 0.000 abstract description 20
- 230000002496 gastric effect Effects 0.000 abstract description 3
- 210000002784 stomach Anatomy 0.000 description 15
- 230000003187 abdominal effect Effects 0.000 description 6
- 230000006378 damage Effects 0.000 description 4
- 230000002745 absorbent Effects 0.000 description 3
- 239000002250 absorbent Substances 0.000 description 3
- 239000000463 material Substances 0.000 description 3
- 206010061245 Internal injury Diseases 0.000 description 2
- 208000027418 Wounds and injury Diseases 0.000 description 2
- 210000003815 abdominal wall Anatomy 0.000 description 2
- 239000002390 adhesive tape Substances 0.000 description 2
- 238000005452 bending Methods 0.000 description 2
- 210000003238 esophagus Anatomy 0.000 description 2
- 239000012530 fluid Substances 0.000 description 2
- 210000004211 gastric acid Anatomy 0.000 description 2
- 208000014674 injury Diseases 0.000 description 2
- 238000003780 insertion Methods 0.000 description 2
- 230000037431 insertion Effects 0.000 description 2
- 239000007787 solid Substances 0.000 description 2
- 241000222120 Candida <Saccharomycetales> Species 0.000 description 1
- 210000001015 abdomen Anatomy 0.000 description 1
- 238000010276 construction Methods 0.000 description 1
- 229910003460 diamond Inorganic materials 0.000 description 1
- 239000010432 diamond Substances 0.000 description 1
- 230000010339 dilation Effects 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 210000004877 mucosa Anatomy 0.000 description 1
- 230000001338 necrotic effect Effects 0.000 description 1
- 230000037361 pathway Effects 0.000 description 1
- 229920003023 plastic Polymers 0.000 description 1
- 239000004033 plastic Substances 0.000 description 1
- 229920002635 polyurethane Polymers 0.000 description 1
- 239000004814 polyurethane Substances 0.000 description 1
- 230000000717 retained effect Effects 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J15/00—Feeding-tubes for therapeutic purposes
- A61J15/0026—Parts, details or accessories for feeding-tubes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J15/00—Feeding-tubes for therapeutic purposes
- A61J15/0015—Gastrostomy feeding-tubes
Definitions
- the present invention relates to stoma devices, particularly, though not exclusively, to stoma devices for maintaining gastrostomy stomas, and to methods of maintaining stomas with such devices.
- the present invention also relates to adhesive dressings.
- a gastrostomy a hollow tube
- Liquid feed may then be supplied through the tube into the stomach.
- gastrostomy tubes may become accidentally removed.
- some known gastrostomy tubes use a balloon located within the stomach to hold them in place, if this becomes deflated the tube may fall out. Damage of the balloon which leads to deflation thereof may for example be caused by Candidas infection.
- stomas are quick to heal and can seal up within a matter of hours. Thus, if a gastromy tube is not quickly reinserted a patient may need to undergo a further gastrostomy operation.
- a gastrostomy tube is not a simple process and must be performed by a qualified medical practitioner.
- a gastrostomy tube may though fall out when such a medical practitioner is not available. It is thus known to employ temporary means to maintain the stoma until a gastrostomy tube can be reinserted.
- One known method employs a Foley Catheter. However such catheters are not intended for this use and there is a risk that they could migrate into and beyond the stomach or become removed themselves.
- EP 1 346 711 A1 discloses a balloon-like member which is received in the bowel and inflated to seal a stoma.
- the member includes a thin, flexible wall defining an opening.
- a flexible dilation tube facilitates insertion of the member and cooperates with a pump to inflate the member.
- the present invention aims to address at least one disadvantage associated with the prior art whether discussed herein or otherwise.
- a stoma device for maintaining a gastrostomy and/or urostomy stoma
- said device comprises a deformable stem having opposed first and second ends, and which is arranged to be inserted through a stoma, and a head which is connected to the stem at its first end and arranged to restrict migration of the stoma device through the stoma; characterised in that the second end of the stem is occluded and rounded; and wherein the stem comprises a side wall which defines a chamber wherein the chamber is an open chamber and one or more openings to the chamber are provided in a side wall or at a first end of the stem but not in both.
- the device is arranged to maintain a gastrostomy stoma.
- the stem is resiliently deformable.
- the stem of the device may be deformable such that, in use, should the free end (second end) of the stem abut an internal body wall, for example the stomach wall, the stem can deform so as to minimise any risk of causing internal injury.
- the second end of the stem is occluded and rounded such that any risk of stem causing internal injury to a patient may be minimised.
- the stem has a rounded second end to minimise the risk of damaging or perforating the stoma mucosa.
- the stem is compressible.
- the stem is compressible in a direction transverse to the axis of the stem.
- the stem comprises a hollow tube.
- the stem is bendable.
- the stem comprises means arranged to control the point at which the stem bends.
- said means comprises one or more weak points along the stems length.
- a weak point may comprise a point along the stems length at which the stem is more prone to collapse.
- a weak point may comprise a thinning of the stem.
- a weak point comprises an aperture in a side wall of the stem.
- the stem is arranged to bend at a point internal of a patients stomach wall.
- a force such as that caused by internal or external pressure, tend to push the stem through the stoma the stem may instead bend.
- the stem may hook around the stomach wall to restrict the stem from exiting the stoma.
- the stem comprises a side wall which defines a chamber wherein the chamber is an open chamber and one or more openings to the chamber are provided in a side wall or at a first end of the stem but not in both such that although the chamber may be open it may not provide a path for fluid to travel through the stoma device either into or out of a patients body.
- the device is arranged such that, in use, there may be an opening into the device lying internal or external of a patient but not both and the device may thus not provide a pathway through the stoma.
- the device may occlude a stoma. This may be important for a number of reasons. For example, whilst it is intended that the device be inserted through both the abdominal and stomach walls a device may, on rare occasions, be incorrectly inserted such that the second end lies in the peritinium (between the stomach and abdominal walls). When so located the device may still provide a benefit by maintaining the abdominal stoma and leaving a surgeon only the stomach stoma to recreate. However, if feed were introduced into the peritinium it could be harmful to a patient. A device which occludes a stoma may though prevent feed being introduced to the peritinium and thus may guard against injury to the patient.
- the first end of the stem is provided with an opening then a corresponding opening is provided through the head of the device.
- the first end of the stem is occluded.
- the first end of the stem may be occluded by the head of the device.
- the side wall of the stem comprises one or more openings.
- the side wall of the stem comprises one or more apertures arrange to lie between 10 and 90% of the stems length from the first end of the stem, more preferably between 30 and 70% of the stems length from the first end.
- the side wall of the stem comprises two apertures.
- said apertures lie on opposed sides of the stem at substantially the same point along the stems length.
- Said apertures suitably provide weak points along the stems longitudinal extent which may control the point at which the stem bends.
- the head comprises one or more retaining members extending substantially transverse to the stems axis.
- the head comprises a retaining member which comprises a disc connected to the stems first end.
- the head comprises handle means by which the device can be held.
- the handle means comprises a button.
- the button may be cylindrical.
- the button extends along the axis of the stem.
- the retaining member or members extend further from the stems axis in a radial direction than does the button.
- the device comprises adhesive attachment means for attaching the device to a patient.
- the adhesive attachment means may comprise an adhesive tape or dressing attached to the head.
- an adhesive tape or dressing is attached to a retaining member.
- the device comprises an adhesive dressing arranged to fit around a button of the device and sit over one or more retaining members.
- the adhesive dressing extends further from the stems axis in a radial direction than does the retaining member or members.
- the adhesive dressing comprises one or more wings for adhering to a patients skin.
- the adhesive dressing comprises an annular disc for attaching to the head and from which extend one or more wings for adhering to a patients skin.
- the adhesive dressing comprises two or more, preferably two wings.
- the dressing may comprise an absorbent layer, which may be a gauze, carrying an adhesive.
- the dressing may comprise a removable cover sheet for covering the adhesive prior to the device being used.
- the dressing is arranged to stretch in a radial direction relative to the stem.
- the dressing suitably comprises a plurality of elongate slits.
- the dressing comprises generally annularly extending slits.
- the dressing comprises slits arranged in concentric arcs.
- slits of one arc are aligned with solid sections of an adjacent arc and vice versa.
- the slits may open out and the dressing may adopt a lattice structure.
- the dressing may accommodate such movement.
- the stoma device may be retained in position more readily than if a known adhesive dressing were used.
- expanding the dressing may reduce pressure at the stoma site and may thus minimise necrotic damage.
- the stem comprises a resiliently deformable material.
- the stem comprises a plastics material, most preferably polyurethane.
- the head may comprise the same material as the stem.
- the head and stem are integral.
- the stem has a length of between 3cm and 8cm, preferably of between 3.5cm and 6.5cm, for example around 6cm.
- the stem has a diameter of between 0.2cm and 2cm, preferably of between 0.4 and 1cm.
- the stem comprises a diameter corresponding to a known French size.
- a gastrostomy tube of a given French size may be used to maintain the Stoma.
- a gastrostomy tube having the same French size as the original tube may subsequently be reinserted through the stoma.
- a method of maintaining a gastric or urostomy stoma which method does not fall within the scope of the present invention but which method employs a stoma device according to the first aspect, comprises inserting a stem of the device through the stoma.
- the method comprises inserting the stem until the head abuts the skin adjacent the stoma and then adhering the device to the skin.
- the method comprises a method of maintaining a gastric stoma.
- the method may be suitable for maintaining a stoma if a gastrostomy tube becomes removed, for example if the tube falls out, until such time as a medical practitioner can reinsert a gastrostomy tube.
- the method comprises inserting the stem through a stoma in the abdomen wall.
- the method further comprises inserting the stem through a stoma in the stomach wall.
- the method can be performed by a person who does not have specific training.
- the method can be performed by a person who does not have medical training.
- the method may be performed by a patients relative.
- the method may provide a temporary means for maintaining a stoma and may not constitute a therapeutic or surgical treatment.
- a medical practitioner can remove the stoma device subsequent to said method being performed in order to reinsert a gastrostomy tube.
- a stoma device 1 comprises a deformable stem 10 having opposed first and second ends 11, 12 and a head 20 formed at the first end 11 of the stem 10.
- the device is arranged to maintain a stoma with the stem 10 being arranged to be passed through a stoma and the head 10 being arranged to prevent the device 1 migrating into the body.
- the stem 10 comprises a hollow tube having a side wall 13 defining a cavity 14.
- the stem 10 is both compressible and bendable.
- the second end 12 of the stem 10 is occluded and rounded so as to minimise risk of causing injury in use.
- Apertures 15 are provided in the stem 10 to form openings into the cavity 14. These apertures 15 create weak points in the stem 10 and thus increase the likelihood of the stem 10 bending at that point. Thus, in use if an internal or external abdominal force causes the second end 12 of the stem to be pushed towards the stoma the stem may bend rather than be forced through the stoma. This bending may also prevent the end 12 damaging the stomach wall.
- the first end 11 of the stem 10 is occluded by the head 20. Thus, there is no through path for fluid to pass through the stoma.
- the head 20 comprises a retaining member in the form of an annular disc 21 and handle means in the form of a button 22 which are coaxial with the stem 10.
- an adhesive dressing 30 Secured to the retaining member is an adhesive dressing 30 for adhering to a patients skin 4 in use.
- the adhesive dressing 30 comprises an annular disc 31 surrounding the button and two opposed wings 32, 33 extending beyond the retaining member disc 21 in a radial direction relative to the stem 10.
- the dressing 30 comprises an absorbent gauze carrying an adhesive and having a plurality of generally annularly extending slits 34 formed therein.
- the dressing may stretch in a direction generally transverse to the slits longitudinal extent to accommodate stretching of the skin such as caused by internal or external abdominal pressure. This may improve patient comfort and reduce movement of the device 1 relative to the stoma which may therefore reduce any risk to the patient.
- a device 1 can be used to maintain the stoma.
- the device 1 can be held by the button 22 and can be inserted into the stoma such that the stem 10 passes through the abdominal wall 2 and stomach wall 3.
- the device is inserted until the disc 21 of the head 20 abuts the skin 4 adjacent the stoma. In use, the head 20 then prevents the device 1 migrating into the stomach.
- the adhesive dressing 30 When the device 1 is in place the adhesive dressing 30 may be pressed onto the skin 4 to fix the device 1 in position. To maintain the dressings adhesive qualities prior to use the dressing 30 comprises a removable cover sheet (not shown) for covering the adhesive.
- Figure 4 illustrates a dressing 100 not falling within the scope of the present invention having a similar construction to that of the dressing 30 employed in the stoma device.
- the dressing 100 comprises an absorbent layer 101, which comprises a gauze, and which carries an adhesive (not shown) on one side thereof.
- an adhesive (not shown) on one side thereof.
- the dressing comprises a removable cover sheet (not shown) for covering the adhesive.
- the dressing 100 comprises a plurality of elongate slits 102 arranged to extend in generally parallel lines orientated in a first direction (arrows A).
- the slits of one line are aligned with solid parts of an adjacent line of slits and vice versa.
- the slits can open out and may adopt a generally diamond form. This may allow the dressing to stretch with the skin and may improve the dressings effectiveness and patient comfort.
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Orthopedics, Nursing, And Contraception (AREA)
- Auxiliary Devices For And Details Of Packaging Control (AREA)
- Addition Polymer Or Copolymer, Post-Treatments, Or Chemical Modifications (AREA)
Abstract
Description
- The present invention relates to stoma devices, particularly, though not exclusively, to stoma devices for maintaining gastrostomy stomas, and to methods of maintaining stomas with such devices. The present invention also relates to adhesive dressings.
- There are known a number of methods of artificially supplying nourishment to patients. One such method comprises forming an incision through the abdominal and stomach walls to create a stoma (a gastrostomy). To provide nourishment a hollow tube (gastrostomy tube) is passed through the stoma such that the tube has an opening within the stomach. Liquid feed may then be supplied through the tube into the stomach. It is important that the gastrostomy tube remains in place to maintain the stoma and to prevent gastric acid egressing through the stoma. However, gastromy tubes may become accidentally removed. For example, some known gastrostomy tubes use a balloon located within the stomach to hold them in place, if this becomes deflated the tube may fall out. Damage of the balloon which leads to deflation thereof may for example be caused by Candidas infection.
- If a tube should become removed it is important that it is replaced speedily to stop gastric acid from exiting the stoma and chemically burning the surrounding skin.
- Additionally, such stomas are quick to heal and can seal up within a matter of hours. Thus, if a gastromy tube is not quickly reinserted a patient may need to undergo a further gastrostomy operation.
- The insertion of a gastrostomy tube is not a simple process and must be performed by a qualified medical practitioner. A gastrostomy tube may though fall out when such a medical practitioner is not available. It is thus known to employ temporary means to maintain the stoma until a gastrostomy tube can be reinserted. One known method employs a Foley Catheter. However such catheters are not intended for this use and there is a risk that they could migrate into and beyond the stomach or become removed themselves.
-
EP 1 346 711 A1 -
EP 1 433 494 A1 - Accordingly, the present invention aims to address at least one disadvantage associated with the prior art whether discussed herein or otherwise.
- According to a first aspect of the present invention there is provided a stoma device for maintaining a gastrostomy and/or urostomy stoma wherein said device comprises a deformable stem having opposed first and second ends, and which is arranged to be inserted through a stoma, and a head which is connected to the stem at its first end and arranged to restrict migration of the stoma device through the stoma; characterised in that the second end of the stem is occluded and rounded; and wherein the stem comprises a side wall which defines a chamber wherein the chamber is an open chamber and one or more openings to the chamber are provided in a side wall or at a first end of the stem but not in both.
- Preferably, the device is arranged to maintain a gastrostomy stoma.
- Suitably, the stem is resiliently deformable.
- The stem of the device may be deformable such that, in use, should the free end (second end) of the stem abut an internal body wall, for example the stomach wall, the stem can deform so as to minimise any risk of causing internal injury.
- Suitably, the second end of the stem is occluded and rounded such that any risk of stem causing internal injury to a patient may be minimised. Suitably, the stem has a rounded second end to minimise the risk of damaging or perforating the stoma mucosa.
- Preferably, the stem is compressible. Preferably, the stem is compressible in a direction transverse to the axis of the stem.
- Suitably, the stem comprises a hollow tube.
- Preferably, the stem is bendable.
- Suitably, the stem comprises means arranged to control the point at which the stem bends. Suitably, said means comprises one or more weak points along the stems length. A weak point may comprise a point along the stems length at which the stem is more prone to collapse.
- A weak point may comprise a thinning of the stem. Suitably, a weak point comprises an aperture in a side wall of the stem.
- Suitably, the stem is arranged to bend at a point internal of a patients stomach wall. Thus, should a force, such as that caused by internal or external pressure, tend to push the stem through the stoma the stem may instead bend. If bent, in use, the stem may hook around the stomach wall to restrict the stem from exiting the stoma.
- Suitably, the stem comprises a side wall which defines a chamber wherein the chamber is an open chamber and one or more openings to the chamber are provided in a side wall or at a first end of the stem but not in both such that although the chamber may be open it may not provide a path for fluid to travel through the stoma device either into or out of a patients body.
- Suitably, the device is arranged such that, in use, there may be an opening into the device lying internal or external of a patient but not both and the device may thus not provide a pathway through the stoma.
- Thus, in use, the device may occlude a stoma. This may be important for a number of reasons. For example, whilst it is intended that the device be inserted through both the abdominal and stomach walls a device may, on rare occasions, be incorrectly inserted such that the second end lies in the peritinium (between the stomach and abdominal walls). When so located the device may still provide a benefit by maintaining the abdominal stoma and leaving a surgeon only the stomach stoma to recreate. However, if feed were introduced into the peritinium it could be harmful to a patient. A device which occludes a stoma may though prevent feed being introduced to the peritinium and thus may guard against injury to the patient.
- Suitably, if the first end of the stem is provided with an opening then a corresponding opening is provided through the head of the device.
- Preferably, the first end of the stem is occluded. The first end of the stem may be occluded by the head of the device.
- Preferably, the side wall of the stem comprises one or more openings. Suitably, the side wall of the stem comprises one or more apertures arrange to lie between 10 and 90% of the stems length from the first end of the stem, more preferably between 30 and 70% of the stems length from the first end.
- Suitably, the side wall of the stem comprises two apertures. Suitably, said apertures lie on opposed sides of the stem at substantially the same point along the stems length.
- Said apertures suitably provide weak points along the stems longitudinal extent which may control the point at which the stem bends.
- Suitably, the head comprises one or more retaining members extending substantially transverse to the stems axis. Preferably, the head comprises a retaining member which comprises a disc connected to the stems first end.
- Preferably the head comprises handle means by which the device can be held.
- Suitably the handle means comprises a button. The button may be cylindrical. Suitably, the button extends along the axis of the stem. Suitably the retaining member or members extend further from the stems axis in a radial direction than does the button.
- Suitably, the device comprises adhesive attachment means for attaching the device to a patient.
- The adhesive attachment means may comprise an adhesive tape or dressing attached to the head. Suitably, an adhesive tape or dressing is attached to a retaining member.
- Preferably, the device comprises an adhesive dressing arranged to fit around a button of the device and sit over one or more retaining members.
- Suitably, the adhesive dressing extends further from the stems axis in a radial direction than does the retaining member or members.
- Suitably, the adhesive dressing comprises one or more wings for adhering to a patients skin.
- Suitably, the adhesive dressing comprises an annular disc for attaching to the head and from which extend one or more wings for adhering to a patients skin. Suitably, the adhesive dressing comprises two or more, preferably two wings.
- The dressing may comprise an absorbent layer, which may be a gauze, carrying an adhesive. The dressing may comprise a removable cover sheet for covering the adhesive prior to the device being used.
- Suitably, the dressing is arranged to stretch in a radial direction relative to the stem.
- The dressing suitably comprises a plurality of elongate slits. Preferably, the dressing comprises generally annularly extending slits. Suitably, the dressing comprises slits arranged in concentric arcs. Suitably slits of one arc are aligned with solid sections of an adjacent arc and vice versa. Thus, when stretched radially the slits may open out and the dressing may adopt a lattice structure.
- Thus, when the skin around a stoma is stretched, for example by inter abdominal movement or compressed by external forces the dressing may accommodate such movement. Thus, the stoma device may be retained in position more readily than if a known adhesive dressing were used. By expanding the dressing may reduce pressure at the stoma site and may thus minimise necrotic damage.
- Suitably, the stem comprises a resiliently deformable material. Suitably, the stem comprises a plastics material, most preferably polyurethane. The head may comprise the same material as the stem. Suitably the head and stem are integral.
- Suitably the stem has a length of between 3cm and 8cm, preferably of between 3.5cm and 6.5cm, for example around 6cm.
- Suitably, the stem has a diameter of between 0.2cm and 2cm, preferably of between 0.4 and 1cm. Suitably, the stem comprises a diameter corresponding to a known French size. Thus, in use, should a gastrostomy tube of a given French size become removed a device of a corresponding French size may be used to maintain the Stoma. Thus, a gastrostomy tube having the same French size as the original tube may subsequently be reinserted through the stoma.
- A method of maintaining a gastric or urostomy stoma, which method does not fall within the scope of the present invention but which method employs a stoma device according to the first aspect, comprises inserting a stem of the device through the stoma.
- Suitably, the method comprises inserting the stem until the head abuts the skin adjacent the stoma and then adhering the device to the skin.
- Suitably, the method comprises a method of maintaining a gastric stoma. The method may be suitable for maintaining a stoma if a gastrostomy tube becomes removed, for example if the tube falls out, until such time as a medical practitioner can reinsert a gastrostomy tube.
- Suitably, the method comprises inserting the stem through a stoma in the abdomen wall. Preferably, the method further comprises inserting the stem through a stoma in the stomach wall.
- Suitably, the method can be performed by a person who does not have specific training.
- Suitably, the method can be performed by a person who does not have medical training. For example the method may be performed by a patients relative.
- The method may provide a temporary means for maintaining a stoma and may not constitute a therapeutic or surgical treatment.
- Suitably, a medical practitioner can remove the stoma device subsequent to said method being performed in order to reinsert a gastrostomy tube.
- The present invention will now be described by way of example, with reference to the drawings that follow, in which:
-
Figure 1 is a perspective view of a stoma device; -
Figure 2 is a cross section showing the stoma device ofFigure 1 in use; -
Figure 3 is a plan view showing the stoma device ofFigure 1 ; and -
Figure 4 is a plan view showing a dressing. - As illustrated by
Figures 1 to 3 astoma device 1 comprises adeformable stem 10 having opposed first and second ends 11, 12 and ahead 20 formed at thefirst end 11 of thestem 10. - The device is arranged to maintain a stoma with the
stem 10 being arranged to be passed through a stoma and thehead 10 being arranged to prevent thedevice 1 migrating into the body. - The
stem 10 comprises a hollow tube having aside wall 13 defining acavity 14. Thestem 10 is both compressible and bendable. - The
second end 12 of thestem 10 is occluded and rounded so as to minimise risk of causing injury in use. -
Apertures 15 are provided in thestem 10 to form openings into thecavity 14. Theseapertures 15 create weak points in thestem 10 and thus increase the likelihood of thestem 10 bending at that point. Thus, in use if an internal or external abdominal force causes thesecond end 12 of the stem to be pushed towards the stoma the stem may bend rather than be forced through the stoma. This bending may also prevent theend 12 damaging the stomach wall. - The
first end 11 of thestem 10 is occluded by thehead 20. Thus, there is no through path for fluid to pass through the stoma. - The
head 20 comprises a retaining member in the form of anannular disc 21 and handle means in the form of abutton 22 which are coaxial with thestem 10. - Secured to the retaining member is an
adhesive dressing 30 for adhering to apatients skin 4 in use. - The
adhesive dressing 30 comprises anannular disc 31 surrounding the button and twoopposed wings member disc 21 in a radial direction relative to thestem 10. - The dressing 30 comprises an absorbent gauze carrying an adhesive and having a plurality of generally annularly extending
slits 34 formed therein. Thus, in use, the dressing may stretch in a direction generally transverse to the slits longitudinal extent to accommodate stretching of the skin such as caused by internal or external abdominal pressure. This may improve patient comfort and reduce movement of thedevice 1 relative to the stoma which may therefore reduce any risk to the patient. - As illustrated by
Figure 2 , if a gastrostomy tube becomes removed adevice 1 can be used to maintain the stoma. Thedevice 1 can be held by thebutton 22 and can be inserted into the stoma such that thestem 10 passes through theabdominal wall 2 and stomach wall 3. The device is inserted until thedisc 21 of thehead 20 abuts theskin 4 adjacent the stoma. In use, thehead 20 then prevents thedevice 1 migrating into the stomach. - When the
device 1 is in place theadhesive dressing 30 may be pressed onto theskin 4 to fix thedevice 1 in position. To maintain the dressings adhesive qualities prior to use the dressing 30 comprises a removable cover sheet (not shown) for covering the adhesive. -
Figure 4 illustrates a dressing 100 not falling within the scope of the present invention having a similar construction to that of the dressing 30 employed in the stoma device. - The dressing 100 comprises an
absorbent layer 101, which comprises a gauze, and which carries an adhesive (not shown) on one side thereof. To maintain the dressings adhesive qualities prior to use the dressing comprises a removable cover sheet (not shown) for covering the adhesive. - The dressing 100 comprises a plurality of
elongate slits 102 arranged to extend in generally parallel lines orientated in a first direction (arrows A). The slits of one line are aligned with solid parts of an adjacent line of slits and vice versa. In use, when applied to the skin, if the skin stretches generally transverse to the slit longitudinal extent (for example in the direction of arrows B) then the slits can open out and may adopt a generally diamond form. This may allow the dressing to stretch with the skin and may improve the dressings effectiveness and patient comfort. - It will be appreciated that preferred embodiments of the present invention may enhance stoma care.
Claims (9)
- A stoma device (1) for maintaining a gastrostomy and/or urostomy stoma wherein said device (1) comprises a deformable stem (10) having opposed first and second ends, and which is arranged to be inserted through a stoma, and a head (20) which is connected to the stem (10) at its first end and arranged to restrict migration of the stoma device (1) through the stoma; characterised in that the second end of the stem (10) is occluded and rounded; and wherein the stem (10) comprises a side wall which defines a chamber wherein the chamber is an open chamber and one or more openings to the chamber are provided in a side wall or at a first end of the stem (10) but not in both.
- A device (1) according to claim 1, wherein the stem (10) comprises a hollow tube.
- A device (1) according to any preceding claim, where the stem (10) is bendable and the stem comprises means arranged to control the point at which the stem (10) bends.
- A device (1) according to claim 3, wherein said means comprises one or more weak points along the stems (10) length.
- A device (1) according to claim 4, wherein a weak point comprises an aperture in a side wall of the stem (10).
- A device (1) according to any preceding claim, wherein the stem (10) is compressible.
- A device (1) according to any preceding claim, wherein the head (20) comprises one or more retaining members extending substantially transverse to the stems (10) axis.
- A device (1) according to any preceding claim, wherein the device (1) comprises adhesive attachment means for attaching the device (1) to a patient and wherein the attachment means comprises an adhesive dressing which comprises one or more wings for adhering to a patients skin.
- A device (1) according to claim 8, wherein the attachment means comprises an adhesive dressing which is arranged to stretch in a radial direction relative to the stem (10).
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
GB0506343A GB2424584A (en) | 2005-03-30 | 2005-03-30 | Stoma device for maintaining a gastrostomy and/or urostomy stoma |
Publications (3)
Publication Number | Publication Date |
---|---|
EP1707177A2 EP1707177A2 (en) | 2006-10-04 |
EP1707177A3 EP1707177A3 (en) | 2006-12-27 |
EP1707177B1 true EP1707177B1 (en) | 2009-09-23 |
Family
ID=34566623
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP06251675A Not-in-force EP1707177B1 (en) | 2005-03-30 | 2006-03-28 | Improvements in and relating to stoma devices and to dressings |
Country Status (6)
Country | Link |
---|---|
US (1) | US20060224131A1 (en) |
EP (1) | EP1707177B1 (en) |
AT (1) | ATE443506T1 (en) |
DE (1) | DE602006009332D1 (en) |
ES (1) | ES2335913T3 (en) |
GB (1) | GB2424584A (en) |
Families Citing this family (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US7661152B2 (en) * | 2007-03-07 | 2010-02-16 | Raul Manzano-Rivera | Gastrostomy garment |
US20100145293A1 (en) * | 2007-07-31 | 2010-06-10 | Verhaalen Amy L | Apparatus and System for Isolating a Fistula |
JP6272625B2 (en) * | 2011-03-03 | 2018-01-31 | ネオダイン バイオサイエンシーズ, インコーポレイテッド | Device and method for skin tightening |
EP3554430A1 (en) * | 2016-12-16 | 2019-10-23 | Avent, Inc. | Medical plug system and apparatus |
CN109431813A (en) * | 2017-08-31 | 2019-03-08 | 美昕医疗器械(昆山)有限公司 | For replacing the device of Gastroenteritic pipe |
Family Cites Families (29)
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US3906951A (en) * | 1974-08-05 | 1975-09-23 | Squibb & Sons Inc | Stomal device including means to prolong attachment of flange |
US3941133A (en) * | 1974-10-04 | 1976-03-02 | E. R. Squibb & Sons, Inc. | Stomal devices having controlled release |
US4192785A (en) * | 1977-06-08 | 1980-03-11 | E. R. Squibb & Sons, Inc. | Ostomy adhesive |
US4187850A (en) * | 1977-12-12 | 1980-02-12 | Gust Charles F | Stoma centering apparatus |
US4351322A (en) * | 1980-10-10 | 1982-09-28 | Prager Elliot D | Stoma control device and method |
FR2556586B1 (en) * | 1983-12-20 | 1988-10-14 | Biotrol Sa Lab | DEVICE FOR THE FLOW OF URINE FROM UROSTOMIES |
US4798592A (en) * | 1984-11-05 | 1989-01-17 | Medical Innovations Corporation | Gastrostomy feeding device |
GB8522037D0 (en) * | 1985-09-05 | 1985-10-09 | Trimark R & D Ltd | Closure device |
US4863438A (en) * | 1985-11-29 | 1989-09-05 | Applied Medical Technology, Inc. | Low profile gastrostomy device |
US4981471A (en) * | 1988-01-15 | 1991-01-01 | Corpak, Inc. | Device for intubation of percutaneous endoscopic ostomy |
US5167627A (en) * | 1990-09-13 | 1992-12-01 | Abbott Laboratories | Stoma creator gastrostomy device and method for placement of a feeding tube |
US5125916A (en) * | 1991-04-04 | 1992-06-30 | Ras Partnership | Stoma cap |
US5330455A (en) * | 1992-04-15 | 1994-07-19 | Mckay Lester M | Enterostomy appliance |
US5413565A (en) * | 1993-01-15 | 1995-05-09 | Sandoz Nutrition Ltd. | Gastrostomy feeding port with elastic adjustable tip |
KR100393364B1 (en) * | 1994-04-29 | 2004-02-18 | 킴벌리-클라크 월드와이드, 인크. | Slit Elastic Fiber Nonwoven Laminate |
US5520662A (en) * | 1994-09-09 | 1996-05-28 | Moss; Gerald | Gastrointestinal aspirating and feeding device with removable sleeve |
US6066112A (en) * | 1996-01-11 | 2000-05-23 | Radius International Limited Partnership | Corporeal access tube assembly and method |
US5607413A (en) * | 1996-03-12 | 1997-03-04 | Dansac A/S | Convex ostomy faceplate with floating flange and finger recess |
US5941860A (en) * | 1997-11-03 | 1999-08-24 | Wheeler; Alton D. | Fecal pouch and installation |
US7087041B2 (en) * | 1998-02-25 | 2006-08-08 | Zassi Medical Evolutions, Inc. | Pad for use with continent ostomy port |
US6039714A (en) * | 1998-05-12 | 2000-03-21 | Novartis Nutrition Ag | Collapsible retention bolster for gastrostomy and other ostomy tubes |
US6045536A (en) * | 1999-02-24 | 2000-04-04 | Sherwood Services, A.G. | Securing device for a low profile gastrostomy tube |
GB9909752D0 (en) * | 1999-04-29 | 1999-06-23 | Hinkles Eric | Tracheostoma button |
US6328720B1 (en) * | 2000-02-18 | 2001-12-11 | Zevex, Inc. | Low-profile enterostomy device |
US6409709B1 (en) * | 2000-05-19 | 2002-06-25 | Sylvia Recto | Ostomy-changing facilitating device |
US20030032932A1 (en) * | 2001-08-09 | 2003-02-13 | Stout Cindy Kay | Feeding tube skin guard |
DE60141362D1 (en) * | 2001-10-03 | 2010-04-01 | Sumitomo Bakelite Co | Ösophagus-stoma-knopf |
US6689111B2 (en) * | 2002-03-22 | 2004-02-10 | Bristol-Myers Squibb Company | Controlled evacuation ostomy device with internal seal |
US6723079B2 (en) * | 2002-03-27 | 2004-04-20 | Bristol-Myers Squibb Company | Controlled evacuation ostomy device with external seal |
-
2005
- 2005-03-30 GB GB0506343A patent/GB2424584A/en not_active Withdrawn
-
2006
- 2006-03-27 US US11/277,571 patent/US20060224131A1/en not_active Abandoned
- 2006-03-28 ES ES06251675T patent/ES2335913T3/en active Active
- 2006-03-28 EP EP06251675A patent/EP1707177B1/en not_active Not-in-force
- 2006-03-28 DE DE602006009332T patent/DE602006009332D1/en active Active
- 2006-03-28 AT AT06251675T patent/ATE443506T1/en not_active IP Right Cessation
Also Published As
Publication number | Publication date |
---|---|
GB0506343D0 (en) | 2005-05-04 |
ATE443506T1 (en) | 2009-10-15 |
EP1707177A3 (en) | 2006-12-27 |
US20060224131A1 (en) | 2006-10-05 |
EP1707177A2 (en) | 2006-10-04 |
GB2424584A (en) | 2006-10-04 |
ES2335913T3 (en) | 2010-04-06 |
DE602006009332D1 (en) | 2009-11-05 |
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